BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON ENDO-SURGERY INC

    MDR report key: 793321 · Received December 12, 2006

    Report

    Report Number
    MW1041313
    Event Type
    Malfunction
    Date Received
    December 12, 2006
    Date of Event
    November 22, 2006
    Report Date
    December 11, 2006
    Manufacturer
    ETHICON
    Product Code
    GDT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    REPROCESSED STAPLER FAILED TO FIRE STAPLES. STAPLER USED TO PUT DRAPES ON AT BEGINNING OF CASE AND MIS-FIRED. NEVER USED ON PATIENT. STAPLER WAS RE-PROCESSED BY ASCENT HEALTHCARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ENDO-SURGERY INC PROXIMATE ROTATING HEAD SKIN STAPLEZ GDT ETHICON * AHS# PRW35

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR